Medtronic Perfusion Systems
Brooklyn Park, MN
This page shows every FDA and USDA recall linked to Medtronic Perfusion Systems. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
121
Total Recalls
2004
First Recall
2026
Most Recent
Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
Apr 29, 2021
· Device
Terminated
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardioto...
Mar 17, 2021
· Device
Terminated
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Ven...
Mar 17, 2021
· Device
Terminated
Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pix...
Mar 17, 2021
· Device
Terminated
Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) wit...
Mar 17, 2021
· Device
Terminated
Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR)...
Mar 17, 2021
· Device
Terminated
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface...
Mar 17, 2021
· Device
Terminated
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir...
Mar 17, 2021
· Device
Terminated
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXY...
Mar 17, 2021
· Device
Terminated
Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Affinity Pixie Cardiotomy/Venous Re...
Mar 17, 2021
· Device
Terminated
Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Ven...
Mar 17, 2021
· Device
Terminated
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1...
Mar 3, 2021
· Device
Active
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Nov 14, 2019
· Device
Terminated
SUCTION / ANTICOAGULATION ASSEMBLY
(a) BTC93
(b) BTC98
Suction and Anticoagulation assemblies are indicated f...
Nov 27, 2018
· Device
Active
RESERVOIR "Y" ADAPTER,
(a) BT920
(b) BT926
Suction and Anticoagulation assemblies are indicated for use with...
Nov 27, 2018
· Device
Active
Extra corporeal circuit with bio-active surface.
Aug 8, 2018
· Device
Terminated
BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I
Product Usage:
The BIO CAL(R) (unit) is a therma...
Feb 8, 2018
· Device
Terminated
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary byp...
Jan 30, 2018
· Device
Terminated
Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540
The AFFINITY(R) NT Cardiotomy/Venou...
Jan 16, 2018
· Device
Terminated
Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T
T...
Jan 16, 2018
· Device
Terminated
DLP Pressure Monitoring Extension Line Adapters
Extends the pressure line in order to reach the pressure monit...
Jul 10, 2017
· Device
Terminated
DLP Extension Line Adapters 20 in length
Used to extend cardioplegia line during cardiopulmonary bypass surger...
Jul 10, 2017
· Device
Terminated
DLP Antegrade/Retrograde Adapter
Method for perfusion of cardioplegia alternately in either an antegrade or re...
Jul 10, 2017
· Device
Terminated
DLP Cardioplegia Adapter with Pressure Port
Provides access for a pressure monitoring needle near the connecti...
Jul 10, 2017
· Device
Terminated
DLP Pressure Disposable Pressure Display Sets
Extends the pressure line in order to reach the pressure monitor...
Jul 10, 2017
· Device
Terminated
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO.
Terumo Cardiovascular Systems (Terumo CVS) has distri...
Feb 26, 2016
· Device
Terminated
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide.
The...
Oct 28, 2015
· Device
Terminated
MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS.
Enables the perfusionist to manage the patient's hematocrit...
Sep 4, 2015
· Device
Terminated
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2...
Sep 4, 2015
· Device
Terminated
Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the...
Aug 19, 2015
· Device
Terminated
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Ki...
Jun 26, 2015
· Device
Terminated
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use,...
Dec 16, 2014
· Device
Terminated
Medtronic Pressure Display Box, Models 66000, 64000, 63000, 60000. It is capable of measuring pressure betwee...
Oct 20, 2011
· Device
Terminated
Medtronic Intersept Custom Tubing Pack, which are designed as specified by the user. The following models con...
Oct 20, 2011
· Device
Terminated
Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide....
Oct 20, 2011
· Device
Terminated
Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable t...
Nov 1, 2010
· Device
Terminated